Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Kent Pharma UK, Itraconazole 10mg/ml Oral Solution |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Kent Pharma UK is recalling two batches of Itraconazole 10mg/ml Oral Solution (batch number: 231069, 231071) as a precautionary measure due to out of specification in the appearance of the solution, particularly the presence of suspended particles or clusters of crystals. Initial investigations indicate this is a solubilisation issue of the active ingredient for the above batches. This means that there is the potential for some doses to have lower active ingredient (itraconazole) in solution. The root cause of this issue is under investigation, but based on the potential for underdosage, the impacted batches are being recalled as a precautionary measure.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-kent-pharma-uk-itraconazole-10mg-slash-ml-oral-solution-el-24-a-slash-26
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Jul 5, 2024
Issued at HKT 16:15
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